PMID- 19138370
OWN - NLM
STAT- MEDLINE
DCOM- 20090817
LR  - 20151119
IS  - 1743-6109 (Electronic)
IS  - 1743-6095 (Linking)
VI  - 6
IP  - 2
DP  - 2009 Feb
TI  - Long-term, multicenter study of the safety and efficacy of topical alprostadil 
      cream in male patients with erectile dysfunction.
PG  - 520-34
LID - 10.1111/j.1743-6109.2008.01118.x [doi]
AB  - INTRODUCTION: Alprostadil is approved for treatment of male erectile dysfunction 
      (ED) by injection or urethral insertion. Topical delivery of alprostadil offers 
      an improved alternative. AIM: To evaluate the long-term safety and efficacy of 
      topical alprostadil cream. METHODS: This was a multicenter, open-label, long-term 
      study in 1,161 patients (998 double-blind rollover; 163 naive) with ED. For the 
      first 4 weeks, patients could administer eight doses of 200 mcg alprostadil to 
      the penis meatus before intercourse (up to 2 per/week). Patients then 
      self-selected to administer 300 or 100 mcg doses if hypo-responsive or 
      hyper-responsive, respectively, or 200 mcg if no change, for up to 9 months (2 
      doses/week). MAIN OUTCOME MEASURES: Safety evaluated patient/partner adverse 
      events (AEs), changes in vital signs, clinical laboratory tests, physical 
      examinations, and electrocardiograms. Efficacy assessed International Index of 
      Erectile Function, Sexual Encounter Profile, Patient Self Assessment of Erection, 
      and Global Assessment Questionnaire. RESULTS: Approximately 12% of patients 
      discontinued due to hypo-/hyper-responsiveness, 16% withdrew consent for a 
      variety of reasons, and less than 5% discontinued because of AEs. The majority of 
      patients (73%) selected 300 mcg alprostadil as the final dose. The most common 
      AEs involved application site burning or erythema (12.2%), meatal or glans pain 
      (4.4%), and prolonged or painful erection (1.3%). Only 5 (0.4%) patients reported 
      a prolonged erection of >or=4 hours (priapism). Vaginal burning or itching (2.1%) 
      was reported most frequently by partners. The majority of patients (74%) 
      demonstrated an overall improvement in erectile function on most end-points, 
      especially after adjusting dose strength to their individual responsiveness. 
      CONCLUSIONS: Topical alprostadil cream was considered effective and safe by most 
      patients and their partners, with most AEs limited to the application site. Dose 
      adjustment to 300 mcg alprostadil facilitated the greatest improvement in 
      erectile function in the majority of patients. A separate report will integrate 
      patient data from the open-label extension and prior double-blind studies.
FAU - Rooney, Michael
AU  - Rooney M
AD  - Radiant Development, Radiant Research Inc., Chicago, IL 60654, USA. 
      michaelrooney@radiantresearch.con
FAU - Pfister, William
AU  - Pfister W
FAU - Mahoney, Mary
AU  - Mahoney M
FAU - Nelson, Melissa
AU  - Nelson M
FAU - Yeager, James
AU  - Yeager J
FAU - Steidle, Christopher
AU  - Steidle C
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20081209
PL  - Netherlands
TA  - J Sex Med
JT  - The journal of sexual medicine
JID - 101230693
RN  - 0 (Dosage Forms)
RN  - 0 (Vasodilator Agents)
RN  - F5TD010360 (Alprostadil)
SB  - IM
MH  - Administration, Topical
MH  - Alprostadil/adverse effects/*therapeutic use
MH  - Dosage Forms
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Electrocardiography
MH  - Erectile Dysfunction/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Priapism/chemically induced/epidemiology
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
MH  - Time Factors
MH  - Treatment Outcome
MH  - Vasodilator Agents/adverse effects/*therapeutic use
EDAT- 2009/01/14 09:00
MHDA- 2009/08/18 09:00
CRDT- 2009/01/14 09:00
PHST- 2009/01/14 09:00 [entrez]
PHST- 2009/01/14 09:00 [pubmed]
PHST- 2009/08/18 09:00 [medline]
AID - S1743-6095(15)32408-5 [pii]
AID - 10.1111/j.1743-6109.2008.01118.x [doi]
PST - ppublish
SO  - J Sex Med. 2009 Feb;6(2):520-34. doi: 10.1111/j.1743-6109.2008.01118.x. Epub 2008 
      Dec 9.